Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation (BFR-TMR-ACL)
Effects of Blood Flow Restriction With or Without Total Motion Release on Strength, Balance and Functional Disability in Postoperative ACL Injury
The aim of this clinical trial is to compare the effectiveness of combined Blood Flow Restriction (BFR) and Total Motion Release (TMR) versus BFR alone in the restoration of muscular strength, balance and knee functionality in men and women aged 16 to 45 years who have undergone primary unilateral ACL reconstruction.
The major research questions that it seeks to address are:
Does the addition of TMR to a BFR protocol lead to significantly higher improvements in absolute quadriceps strength and subjective knee functioning as measured by IKDC scores? Does the combined protocol lead to better functional balance and symmetry in terms of the Single Leg Stance (SLS) test and Limb Symmetry Index (LSI)? The researchers will compare the BFR + TMR group to the BFR-only group to determine whether the integrated approach speeds up functional recovery and alleviates neuromuscular control deficits more effectively than strength-focused training alone.
Participant TasksParticipants will: Undergo 3 sessions/week of supervised rehabilitation over a 6 month period. Complete Blood Flow Restriction (BFR) training consisting of low-load exercises (mini squats and knee extensions) with an inflatable cuff placed around the proximal part of the thigh at 60-80% occlusion pressure. Should there be in the experimental group, Total Motion Release (TMR) exercises (e.g., trunk rotations and hip shifts) on the contralateral side (i.e. non-painful side) to correct movement asymmetries before the BFR training. Baseline, 6 weeks, 12 weeks, and 6 months of complete subjective self-assessments (IKDC forms) and objective physical tests (dynamometer strength testing and single-leg balance tests).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Evaluate and compare the effectiveness of Blood Flow Restriction (BFR) therapy as a single intervention against a combined protocol of Blood Flow Restriction and Total Motion Release (BFR+TMR) in men and women aged 16-45 who had undergone primary unilateral ACL reconstruction. The study aimed to address persistent deficits in quadriceps strength, neuromuscular control, and movement symmetry that often remain after standard rehabilitation.
The main questions it aimed to answer were:
Did the integration of TMR-a method focused on movement symmetry-into a BFR protocol lead to superior improvements in absolute quadriceps strength and subjective knee function as measured by IKDC scores? Did the combined BFR+TMR protocol result in significantly better functional balance and limb symmetry compared to BFR training alone? Researchers compared a BFR+TMR experimental group to a BFR-only control group. The primary objective was to see if the combined approach, which targeted both peripheral muscle capacity (via BFR) and central neuromotor control (via TMR), provided a more holistic and accelerated recovery than targeting muscular adaptations alone.
Complete a 6-month rehabilitation program consisting of supervised sessions three times per week.
Perform Blood Flow Restriction (BFR) training on the affected limb using an inflatable cuff at 60-80% occlusion pressure during low-load resistance exercises such as mini squats and knee extensions.
If assigned to the experimental group, perform Total Motion Release (TMR) exercises (including trunk rotations, side bending, and hip shifts) on the non-painful, contralateral side prior to the strengthening exercises.
Undergo periodic assessments including isometric strength testing with a dynamometer, the Single Leg Stance (SLS) test for balance, and the completion of the IKDC Subjective Knee Form.
Maintain a record of progress across four specific time points: baseline, 6 weeks, 12 weeks, and 6 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Punjab Province
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Lahore, Punjab Province, Paquistão, 54000
- Green International University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 16-45 years.
- Both male and female patients.
- Underwent primary unilateral ACL reconstruction (hamstring or patellar tendon autograft).
- 2-4 weeks post-operative and cleared for supervised rehabilitation.
- Willing and able to provide informed consent.
Exclusion Criteria:
- Revision ACL surgery or multi-ligament injury.
- Concomitant fracture or meniscal repair requiring restricted rehab.
- History of DVT, vascular disease, uncontrolled hypertension, or cardiovascular disease.
- Neurological disorders affecting lower limb strength or balance.
- Contraindications to BFR (pregnancy, clotting disorders).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: BFR + TMR Group
Describe the Blood Flow Restruction and the Total Motion Release exercises
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Blood Flow Restriction (BFR): Use the exact same cuff and pressure settings as Group 1 so the comparison is fair. The Exercises: List the specific movements (e.g., Straight Leg Raises, Quad sets, or Knee Extensions). The Difference: State clearly: "This group receives standard BFR training and traditional physical therapy without any TMR protocols." Blood Flow Restriction (BFR): Specify the cuff type (e.g., automated or manual), the width of the cuff, and the pressure used (e.g., 80% of Limb Occlusion Pressure). Total Motion Release (TMR): Explain that you are using the "TMR protocol." Mention that you treat the "good" side or the "non-painful" side to influence the injured side. The Dose: How many minutes? How many times per week? (e.g., 30-minute sessions, 3 times per week for 12 weeks). The Difference: State clearly: "This group receives the TMR balancing protocol in addition to standard BFR training." |
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Comparador Ativo: BFR Only Group
Describe only the blood flow restriction part.
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Blood Flow Restriction (BFR): Use the exact same cuff and pressure settings as Group 1 so the comparison is fair. The Exercises: List the specific movements (e.g., Straight Leg Raises, Quad sets, or Knee Extensions). The Difference: State clearly: "This group receives standard BFR training and traditional physical therapy without any TMR protocols." |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Maximum Isometric Lower Limb Strength
Prazo: Basaeline, 6 weeks, 12 weeks and 6 months.
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Maximum isometric force of the affected limb measured using a hand-held dynamometer.
This assesses the recovery from muscle atrophy and the return of power during the rehabilitation period.
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Basaeline, 6 weeks, 12 weeks and 6 months.
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Single Leg Stance (SLS) Test Time
Prazo: Basaeline, 6 weeks, 12 weeks and 6 months.
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The duration a participant can stand unassisted on the injured leg without moving or compensating.
This test determines the regain of static balance and proprioception.
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Basaeline, 6 weeks, 12 weeks and 6 months.
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Total Score of International Knee Documentation Committee (IKDC) Subjective Knee Form
Prazo: Baseline, 6 weeks, 12 weeks, and 6 months.
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The IKDC Subjective Knee Form is a patient-reported outcome measure used to assess functional disability.
It combines 18 items covering three domains: symptoms, physical activity, and knee function.
All individual items are summed and transformed into a total score.
A score of 100 indicates no limitation in activities of daily living or sports, while a score of 0 indicates maximum limitation.
This measure provides a single aggregated value of the participant's self-reported functional status.
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Baseline, 6 weeks, 12 weeks, and 6 months.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GIU/REC/26-30 (Outro identificador: Research Ethical Committee, Green International University)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
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